hemochroma PLUS System— 510(k) K182298
Substantially EquivalentImmunostics Inc.,
FDA 510(k) clearance K182298 for hemochroma PLUS System, Substantially Equivalent on 2018-11-16. Applicant: Immunostics Inc.,.
Clearance details
- Applicant
- Immunostics Inc.,
- Product code
- Code GKR
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Eatontown, NJ, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.